Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

New Drugs And Therapeutic Biologics Approved In 2016

Executive Summary

Interactive chart of 2016 novel approvals from US FDA's Center for Drug Evaluation and Research.

FDA's Center for Drug Evaluation and Research approved 22 new molecular entities and novel therapeutic biologics in 2016.

The approvals chart below can be searched and sorted. Click on a column header to sort by that parameter, including sponsor, approval date, indication, and designations. Use the "search" box to filter the data. Searching by "priority" or "orphan," for example, will display only priority review or orphan drug approvals. To keep the size of the chart in check, breakthrough therapy designations are listed as "BTD" and products approved under accelerated approval regulations are designated "AA."

The Pink Sheet keeps ongoing track of new drug and therapeutic biologic approvals on the FDA Performance Tracker's Novel CDER Approvals page.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119756

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel